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NCT04504916 · ClinicalTrials.gov registry record · Phase 2

A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)

A Phase 2 study, sponsored by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Terminated
Registry status
Phase 2
Development phase
102
Enrollment target

NCT04504916: Clinical Trial Phase 2 study, sponsored by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

NCT04504916 is a Phase 2 study that was terminated before completion, run by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 102 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04504916, a Phase 2 study, was terminated before completion, sponsored by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

TERMINATED
Registry status
Phase 2
Development phase
102 participants
Enrollment target

Study Summary

This is a study evaluating the efficacy, safety, and pharmacokinetics of zilovertamab vedotin in participants with metastatic solid tumors including previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC human epidermal growth factor receptor 2 (HER2)-negative breast cancer, non-squamous non-small-cell lung cancer (NSCLC), gastric cancer, pancreatic cancer, and platinum-resistant ovarian cancer. The study will evaluate a null hypothesis that the objective response rate (ORR) is ≤5% against the alternative hypothesis that it is ≥20%.

Primary Outcome

The percentage of participants who achieved a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) using per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 by BICR was reported.

Interventions

  • DRUG Zilovertamab vedotin

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2020-10-07
Est. Completion 2023-06-12
Phase Phase 2

Why NCT04504916 stopped before completion

NCT04504916 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 1 intervention - of which Zilovertamab vedotin is the first listed.

NCT04504916 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04504916 about?

NCT04504916 is a clinical study titled "A Study of Zilovertamab Vedotin (MK-2140/VLS-101) in Participants With Solid Tumors (MK-2140-002)". This is a study evaluating the efficacy, safety, and pharmacokinetics of zilovertamab vedotin in participants with metastatic solid tumors including previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC human epidermal growth factor receptor 2 (HER2)-negative breast cancer, no...

What is the current status of trial NCT04504916?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2020-10-07. Estimated completion is 2023-06-12.

What interventions are being tested in trial NCT04504916?

The interventions under investigation include: Zilovertamab vedotin (DRUG).

Who is sponsoring clinical trial NCT04504916?

This trial is sponsored by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04504916's enrollment target sits among peer trials

102 668th of 2000 higher than 1,329 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04504916, the US trial registry maintained by the National Library of Medicine. NCT04504916 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.